Glycine, N-acetyl-N-[3-(trifluoromethyl)phenyl]valyl-, ethyl ester

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Administrative data

Endpoint:

relative self-ignition temperature (solids)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is a solid having a melting point <= 160°C

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

melting point/freezing point

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 102 (Melting point / Melting Range)

Version / remarks:

-

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method A.1 (Melting / Freezing Temperature)

Version / remarks:

-

Deviations:

no

GLP compliance:

no

Type of method:

capillary method

Specific details on test material used for the study:

- Analytical purity: 98.5% (HPLC)- Lot/batch No.: 0161045- Expiration date of the lot/batch: 2018/06/16

Key result

Melting / freezing pt.:

>= 94.3 - <= 96.3 °C

Atm. press.:

ca. 1 atm

Decomposition:

no

Findings

Pre-Test

The test substance started to melt at 96.2 °C and was completely melted to a clear colourless liquid at 97.0 °C.

Main Study

The following values were recorded:

Melting Point/Range	Begin	End
First determination	94.3 °C (367.5 K)	96.3 °C (369.5 K)
Second determination	94.2 °C (367.4 K)	96.2 °C (369.4 K)

 

Results and Validity

Result Test substance MEXORYL SAR/20

The mean between both determinations gives the following value for the melting range:

Melting range:                         94.3 to 96.3 °C (367.5 to 369.5 K)

Standard deviation:                  0.1 (begin); 0.1 (end)

Estimated accuracy:                ± 0.1 °C

Validity

All validity criteria were met, as can be taken from the following table.

Parameter	Criterion	Found	Assessment
Difference between duplicate determinations	=< 0.5 K	0.1 K	valid
Difference between begin and end of melting process	=< 0.5 K	2.0 K	melting range is stated

 

Conclusions:

The mean between both determinations gives the following value for the melting range:Melting range: 94.3 to 96.3 °C (367.5 to 369.5 K)

Executive summary:

The melting point of the test item has been determing with a not-GLP compliant study, according to standard guideline OECD TG 102. The capillary method using an aluminium block was used.

The test tube containing the capillary tube with the test substance was set into the block for melting points at 80.0 °C (first determination and 80.5 °C second determination). For the increase of the temperature, a temperature gradient of =< 1 °C/min was maintained. The temperature, at which the first signs of changes of the test substances could be observed, was noted.

The mean between both determinations gives the following value for the melting range:

Melting range: 94.3 to 96.3 °C (367.5 to 369.5 K).

All validity criteria were met.